Abstract: Implantable device, such as a femoral head prosthesis, with a body (12) of biocompatible material shaped to suit its medical function, which forms an internal cavity (16) and has open apertures (18) that lead from the cavity (16) to the outside. The cavity (16) serves to receive spongiosa or other biological material into which the tissue that surrounds the implanted device is intended to grow through the apertures (18). The device is provided with at least two electrodes (30, 32), at least one of which is located in the cavity (16) spaced apart from the inside of the body (12) that forms the cavity (16). The electrodes are provided with an arrangement for supplying a low-frequency alternating voltage, so that by means of the supplied voltage a low-frequency electrical alternating field and a low-frequency alternating current, whereby the tissue growth is promoted, are created inside the cavity (16).

Abstract: A push-up bra has an envelope between the front panel and the rear panel of the bra cups, that receives a flexible pouch containing a mixture of water and a hygroscopic agent such as 70% glycerine--30% water. The hygroscopic agent will draw moisture into the envelope preventing the volume of liquid from decreasing.

Abstract: Crosslinked compositions formed from a water-insoluble copolymer are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two crosslinkable functional groups per polymer chain. These compositions are able to form hydrogels in aqueous environments when crosslinked. These hydrogels are good sealants for implantable prostheses when in contact with an aqueous environment. In addition, such hydrogels can be used as delivery vehicles for therapeutic agents.

Abstract: A rheologically modified, osmotically balanced dispersion for an implant for the body. The dispersion includes an osmotic control agent of preferably polyvinylpyrrolidinone, a rheological agent of preferably guar gum, and an antimicrobial. Methods for filling an implant are also disclosed. The osmotic control agent or first polymeric agent is present in the dispersion in an amount effective to substantially balance the osmotic pressure of the implant with the osmotic pressure of the portion of the body into which it is implanted. The rheological agent or second polymeric agent forms a three-dimensional network and is present in the dispersion in an amount effective such that the fill material is pseudoplastic. Both the first and second polymeric agents are biocompatible.

Abstract: A passive transponder may be encoded with a number or code of up to 64 binary bits and then associated with or mounted to virtually any living tissue implant for implantation in a human. After implantation, the transponder's code may be conveniently read with a hand held electromagnetic reader which may merely be brought within proximity of the transponder. The encoded transponder may thus be read in a non-invasive procedure and without the use of any sophisticated or potentially harmful medical equipment or technology such as X-ray. The information encoded in the transponder may correspond to patient demographics and implant data to aid in tracking the implant's progress and use for medical as well as legal reasons.

Abstract: An implantable body including an outer membrane forming an enclosure for receiving a filler material. The surface of the outer membrane is characterized by a random distribution of peaks separated by valleys. The peaks and valleys are separated by gradual contoured slopes with a smooth transition between the peaks and valleys which are substantially free from indentation. The enhanced surface provides improved anchoring of the implant, yet reduces host reaction. The enhanced surface is formed by depositing a distribution of cured polymeric particles on an uncured tacky surface. This intermediate surface is then cured, followed by application of a layer of uncured elastomeric material. The entire surface is then cured to form the enhanced surface.

Abstract: An improved mammary prosthesis for implantation in humans comprising: a soft, flexible outer membrane forming an enclosure for receiving a filler material; an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes and terraces without interstices disposed over at least a portion of said outer membrane; an internal structure within said membrane for supporting said outer membrane and providing an enhanced, life-like look and feel to the prosthesis; and a soft, partially-deformable, elastic filler material received within said outer membrane and cooperating with said internal structure to support said outer membrane.

Abstract: A new soft tissue implant filling material is disclosed. The surgically implantable soft tissue implant filling material has good aesthetic properties, as measured by viscosity and elasticity, and good elimination properties. One embodiment of such a new filling material is a gel which comprises three components. The first component is a water soluble polymer or hydrogel that has a high molecular weight. Alternatively, the first component is both crosslinked and has a high molecular weight. The second component of the filling material is a water-soluble polymer that is eliminated rapidly through the kidneys upon subcutaneous release. The third component of this filling material is saline, which is used to dissolve the polymer and to adjust the osmolality of the polymer. In addition, a buffer may be added to the filling material to adjust the pH of the gel. One gel formulation of the present invention, in its preferred embodiment, consists of polyacrylamide and derivatives thereof.

Abstract: A procedure for breast reconstruction with a tissue flap having a cutaneous skin island. The procedure is performed as a total, immediate reconstruction, or on a delayed basis of reconstruction. The tissue flap is a free flap or a flap attached via a native vascular pedicle. Forces acting on the skin island yield enhanced nipple-areolar projection of the reconstructed-breast.

Abstract: A method of manufacturing a laminated item such as a prosthesis or tissue expander having a flexible, expandable membrane surrounding an interior lumen to enhance the strength and performance of the membrane comprises the steps of applying a first layer of a fluid, resilient, stretchable material to a mandrel; allowing the fluid material to drain off the mandrel in a first flow direction; allowing the fluid material to harden to form a resilient, stretchable first layer on the mandrel; applying a second layer of the fluid material on the first layer; changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in a second flow direction, the second flow direction being at an angle to the first flow direction; and allowing the fluid material to harden to form a resilient, stretchable second layer on the first layer.

Abstract: A permanent, biocompatible material for soft tissue augmentation. The biocompatible material comprises a matrix of smooth, round, finely divided, substantially spherical particles of a biocompatible ceramic material, close to or in contact with each other, which provide a scaffold or lattice for autogenous, three dimensional, randomly oriented, non-scar soft tissue growth at the augmentation site. The augmentation material can be homogeneously suspended in a biocompatible, resorbable lubricious gel carrier comprising a polysaccharide. This serves to improve the delivery of the augmentation material by injection to the tissue site where augmentation is desired. The augmentation material is especially suitable for urethral sphincter augmentation, for treatment of incontinence, for filling soft tissue voids, for creating soft tissue blebs, for the treatment of unilateral vocal cord paralysis, and for mammary implants. It can be injected intradermally, subcutaneously or can be implanted.

Abstract: Soft tissue implants can be constructed by forming an outer membrane into a closed pouch and filling material in that pouch. A composition for use as a filler material in such a soft tissue implant may include elastin and collagen. The filling material has collagen as a component thereof, and this collagen can be cross-linked or not cross-linked. Methods of making such implants are described.

Abstract: The human breast is enhanced by enlargement by inserting body compatible fluids into the natural lactatous containments within the breast by flowing the liquid into the lactatous duct openings at the nipples. Flow is induced, from a source of pressurized fluid, by directing a jet of liquid into the duct opening, by pressing the fluid conductor against the opening or by penetrating the opening with a blunt needle or equivalent catheter. To ease penetration of the opening, suction apparatus is offered that distends the nipple to straighten the duct. Plugs are offered to enhance the fluid retention ability. The plug may be solid or valved to allow fluid flow only when a handling tool is inserted to manipulate the plug. Fluid emulsification apparatus is provided to condition fluids which may include saline aqueous liquid, compressible fluid, and autogenous materials individually or in combinations.

Abstract: A dissection glove for forming in a patient a tissue pocket to receive an implantable device. The dissection glove is constructed of an absorbent material formed into at least one recess with an open end for receiving a portion of a surgeon's gloved hand. A retaining mechanism is provided for releasably retaining the dissection glove to a portion of the surgeon's gloved hand. An extraction mechanism is optionally provided for extracting the dissection glove from the tissue pocket. The dissection glove may be constructed from a variety of materials, such as polypropylene nonwoven mesh or calcium alginate gauze. The present invention is also directed to a method of forming a tissue pocket in a patient for receiving an implantable device using the present dissection glove.

Abstract: An attachable two-chamber breast prosthesis includes two volumes of silicone materials that have different degrees of softness. The prosthesis includes three pieces of polyurethane film (a front film, a middle film, and a rear film) that form a front chamber and rear chamber. The periphery of the front chamber is smaller than the periphery of the rear chamber. The rear chamber, which contains the firmer silicone material, extends to the peripheral edge of the prosthesis. The front chamber, which contains the softer silicone material, does not extend all the way to the peripheral edge along the upper region of the prosthesis. By increasing the thickness of the rear chamber along a boomerang-shaped region defined by the peripheries of the front and rear chambers, the firmer silicone material in the rear chamber provides the prosthesis with proper support and reduces the tendency of the prosthesis to pull away from the skin along the top edge of the prosthesis.

Abstract: The invention relates to a mechanical tissue expansion device for use in the reconstruction or augmentation of a portion of an individual's body. The invention includes a pair of tissue expansion plates which may be substantially flat or which may include an arcuate curved shape. Each of the tissue expansion plates has a plurality of apertures therethrough in order to facilitate the ingrowth of natural tissue within an enlarged cavity. The tissue expansion plates are mechanically separated by a means for expansion which preferably includes a cylinder having three telescopically expanding rods engaged thereto. The means for expansion is incrementally regulated by an operating means. The operating means preferably includes tubing engaged to the cylinder and to a port having a silicone membrane, for receipt of incremental portions of saline solution or water for telescopic expansion of the rods from the cylinder.

Abstract: A combination tissue dissector and long term expander is disclosed for use in plastic surgery applications and other applications where it is desirable to dissect a tissue pocket and serially expand the dissected pocket through long term tissue expansion. The combination device performs the separate functions of dissection and long term expansion in a single balloon package. In an exemplary embodiment, three sheets of substantially inelastic material are bonded together at their outer margins to form two discrete inflatable chambers. The lower inflatable chamber defined by the middle and lower balloon sheets is further welded together at various points over the sheet's surface area to create a semi-rigid base portion which provides a flat well-defined footprint for the balloon. The semi-rigid base prevents further enlargement of the tissue pocket at the margins when the device is utilized as a tissue expander.

Abstract: A medical device for implantation in the tissue of a human body having a biocompatible coating thereon including a foreign body formed of a material which is substantially biocompatible with the tissue of the human body. The foreign body has a surface adapted to come in contact with the tissue of the human body and is capable of being oxidized. An organic linker is carried on the surface and forms an oxidative coupling with the surface. A bioactive agent is bonded to the organic linker by a chemical reaction or photochemical function.

Abstract: A combination tissue dissector and long term expander is disclosed for use in plastic surgery applications and other applications where it is desirable to dissect a tissue pocket and serially expand the dissected pocket through long term tissue expansion. The combination device performs the separate functions of dissection and long term expansion in a single balloon package. In an exemplary embodiment, three sheets of substantially inelastic material are bonded together at their outer margins to form two discrete inflatable chambers. The lower inflatable chamber defined by the middle and lower balloon sheets is further welded together at various points over the sheet's surface area to create a semi-rigid base portion which provides a flat well-defined footprint for the balloon. The semi-rigid base prevents further enlargement of the tissue pocket at the margins when the device is utilized as a tissue expander.

Abstract: A bioresorbable sealant composition useful for impregnating implantable soft-tissue prostheses includes at least two polysaccharides in combination to form a hydrogel or sol-gel. The sealant compositions may optionally include a bioactive agent and/or be cross-linked subsequent to application of these compositions to the substrate surface.

Abstract: A breast implant comprising a plurality of bags filled with a fluid and each having, when at rest, a predetermined configuration. Each of the bags is defined by a flexible membrane. A means, particularly an outer shell, is provided to hold the bags together.

Abstract: A device for implant having a biocompatible membrane coating. The membrane comprises a closely packed array of self-assembling amphiphilic molecules and two ionophore components. A receptor molecule reactive with the analyte is provided on one of the ionophore components. The binding of the analyte to the receptor molecule causes a change in the relationship between the ionophore components such that the flow of ion across the membrane is prevented or allowed. The ionophore components are preferably selected from the group consisting of amphotericin B, gramicidin A monomers and combinations thereof, with gramicidin A monomers being particularly preferred. The present invention also provides a membrane including receptors directed against the Fc region of antibodies. These receptors are preferably derived from polyclonal antibodies. These membranes provide a "generic" surface which will bind antibodies in a manner such that the antigen binding regions of the antibody are not hindered.

Abstract: A surgical method for breast reconstruction, comprising steps of placing a submuscular breast expander beneath a muscle; expanding the breast for a period of time that permits neovascular connections to grow between the muscle and cutaneous tissue which overlays the muscle; and, surgically reconstructing a nipple from the neovascularized cutaneous tissue overlaying the muscle, whereby the expanding step directly contributed an amount of tissue that permitted achievement of the breast reconstruction. The step of recreating the nipple areolar complex can comprise performing a bowtie reconstruction technique.

Abstract: The invention relates to a tissue implant having visco-elastic characteristics which simulate the natural tissue that is intended to be augmented or replaced. The implant is comprised of a shell or envelope enclosing a compound foam body and a fluid filler material. Both the foam body and the fluid filler are should be biocompatible and preferably are substantially radiolucent using standard mammographic materials and protocols. The compound foam body is of elastomeric cellular foam materials. Intercellular communication of the fluid filler provides a hydraulic mechanism for imparting shape and tissue-like consistency to the implant. The compound foam body has multiple regions, each region having a different cellular density, for simulating the tactile characteristics of the natural tissue that the implant is intended to augment or replace. The implant may also have a cavity in the compound foam body configured for providing a hydraulic reservoir for the fluid filler.

Abstract: A human part model is formed by spraying a layer of uncured silicone mixed with a catalyst and a solvent carrier onto the inside of a mould cavity. Next a model base is clamped to the mould and a body of uncured silicone gel mixed with a catalyst injected to fill the mould between the base and the layer. As the silicone layer cures, it adheres to the body of silicone gel, thereby enhancing the life-likeness of the resulting model. A breast cyst model may be formed by adding an elastomeric bulb to the base prior to clamping the base to the mould. The inlet of the bulb is inserted onto a passageway through the base, which passageway has a one-way valve to prevent backflow from the bulb. The hardness and thickness of the bulb is chosen so that it reseals after being needled.

Abstract: The human breast is enhanced by enlargement by inserting body compatible fluids into the natural lactatous containments within the breast by flowing the liquid into the lactatous duct openings at the nipples. Flow is induced, from a source of pressurized fluid, by directing a jet of liquid into the duct opening, by pressing the fluid conductor against the opening or by penetrating the opening with a blunt needle or equivalent catheter. To ease penetration of the opening, suction apparatus is offered that distends the nipple to straighten the duct. Plugs are offered to enhance the fluid retention ability. The plug may be solid or valved to allow fluid flow only when a handling tool is inserted to manipulate the plug. Fluid emulsification apparatus is provided to condition fluids which may include saline aqueous liquid, compressible fluid, and autogenous materials individually or in combinations.

Abstract: An implant and coverings for an implant for use in the human body are disclosed. Coverings for implants are constructed to present a biocompatible surface to the body and to provide a textured surface which serves to disorganize scar tissue which forms around the implant. Filaments of expanded PTFEe are attached to a stretch fabric backing in a loose weave configuration. Silicone molded in geometric patterns may be employed to present a textured surface. Compressive structures may be beneficially used on the surface of the implant or in the interior of the implant. Foam is one such compressive structure. Hexagonally shaped compressive cells containing fluid, gas, gel or foam are adapted to receive an insert which contains an outer biocompatible coating. A valve or port is provided to communicate between the cell and the body. Expansion means may be provided to expand the implant in a desired direction.

Abstract: A procedure for breast reconstruction with a tissue flap having a cutaneous skin island. The procedure is performed as a total, immediate reconstruction, or on a delayed basis of reconstruction. The tissue flap is a free flap or a flap attached via a native vascular pedicle. Forces acting on the skin island yield enhanced nipple-areolar projection of the reconstructed breast.

Abstract: The methods and apparatus of the present invention permit a stable body pocket to be formed utilizing multiple biocompatible sheets or using only a single biocompatible sheet positioned to create either a potential space or actual space stable body pocket. The sheets have one surface which permits tissue ingrowth and thereby stably secures the sheet in the desired position. The other sheet surface is non-adhering such that adherence to a facing surface does not occur thereby creating a stable body pocket. In addition, a stable body pocket can be formed by using a biocompatible sheet or sheets having a surface that is selectively capable of permitting tissue ingrowth such that some portions of the surface grows into the surrounding tissue and other portions of the surface do not adhere to the surrounding tissue. In this manner, the stable body pocket apparatus has flexible surface portions. Stable body pocket access channels can also be formed according to the methods and apparatus of the present invention.

Abstract: A medical device having a bio-active coating is prepared by providing a polymeric substrate having hydroxyl and/or amine functionality on a surface thereof and applying the bio-active coating to the surface. The bio-active coating is the reaction product of two different reactions. The first reaction includes reacting the polymeric substrate with a hydrophilic, isocyanate-terminated spacer having at least one isocyanate group at its first and second ends. The second reaction includes reacting a remaining, unreacted isocyanate-terminated end of the spacer with a bio-active agent to bond the bio-active agent to the spacer.

Abstract: A tool and method for introducing an implant through an incision in a body utilizing a tube having a hole through which the implant is pressed. In the preferred embodiment, a two part tube has one opened end and one closed end. The tube contains an expanding structure, for applying pressure on the implant, optionally a pressure transmitting structure, and an implant. The expanding structure is expanded optionally by gas or fluid filling the structure. Optionally, a collar is disposed around the tube near the opening, selectively covering and uncovering a cut-out in the tube which permits manipulation of the implant prior to insertion.

Abstract: Methods and compositions are described herein for reconstruction or augmentation of breast tissue. Dissociated cells, preferably muscle cells, are implanted in combination with a suitable biodegradable, polymeric matrix to form new tissue. There are two forms of matrices which can be used: a polymeric hydrogel formed of a material such as alginate having cells suspended therein, and a fibrous matrix having an interstitial spacing between about 100 and 300 microns. Preferred polymeric materials are those degrading over about one to two months, such as polylactic acid-glycolic acid copolymers. The matrices can be seeded prior to implantation or implanted, allowed to vascularize, then seeded with cells. In a preferred embodiment, the cell-matrix structures are implanted in combination with tissue expander devices. As cell-matrix is implanted, or cells proliferate and form new tissue, the expander size is decreased, until it can be removed and the desired reconstruction or augmentation is obtained.

Abstract: A passive transponder may be encoded with a number or code of up to 64 binary bits and then associated with or mounted to virtually any living tissue implant for implantation in a human. After implantation, the transponder's code may be conveniently read with a hand held electromagnetic reader which may merely be brought within proximity of the transponder. The encoded transponder may thus be read in a non-invasive procedure and without the use of any sophisticated or potentially harmful medical equipment or technology such as X-ray. The information encoded in the transponder may correspond to patient demographics and implant data to aid in tracking the implant's progress and use for medical as well as legal reasons.

Abstract: An injectable or implantable material for soft tissue augmentation comprising a hydrogel containing both hydrophobic and hydrophilic domains is prepared by copolymerizing a hydrophilic monomer, such as water soluble N-vinylpyrrolidone with non-water soluble monomers, such as N-vinyl carbazole, its derivatives, or a non-water soluble derivative of N-vinylpyrrolidone. Also suitable for injection into direct contact with body tissue are hydrogels prepared by cross-linking polyvinylpyrrolidone. The hydrogel may be either solid or composed of particles. The hydrogel may also be enclosed within a flexible porous or nonporous envelope.

Abstract: This invention provides prostheses for implantation into human soft tissue. One aspect of this invention provides soft tissue prostheses comprising a physiologically compatible containment sac and, contained within said sac, a normal body constituent comprising a glycosaminoglycan, mucopolysaccharide, or any other naturally occurring, highly viscous filling material known to be rapidly resorbed from tissues or known to cause little adverse tissue reaction. Also provided by this invention are methods for recontouring soft tissue at a selected body location and methods for decreasing the risk of adverse physiological reaction to an implant.

Abstract: An orbital implant is provided with a passageway extending from the anterior surface inwardly to receive a peg prior to implantation in the patient. The peg is made of non microporous material so that surrounding tissue will encapsulate the peg without adhering to it. A cap of absorbable bio-material is placed in front of the implant so as to create a cushion between the implant and the ocular prosthesis. The peg provides for later coupling of the ocular prosthesis to the implant without the necessity of a second operative procedure, and also allows the peg to be easily removed surgically if deemed necessary by the surgeon. The implant itself can be of any suitable material, but the implant is preferably made of biodegradable material having a matrix with random voids throughout to enhance tissue ingrowth into the implant.

Abstract: An expansion device for oral reconstruction formed by a closed pouch made of a film provided at one point with an additional thickness and a protective feature against being perforated right through, characterized in that the protective feature is a concave cover portion within the pouch and is positioned so as to be facing the additional thickness, bonded directly to each side of the additional thickness but not on its entire periphery.

Abstract: Soft tissue implants can be constructed by forming an outer membrane into a closed pouch and filling material in that pouch. A composition for use as a filler material in such a soft tissue implant may include elastin and collagen. The filling material has collagen as a component thereof, and this collagen can be cross-linked or not cross-linked. Methods of making such implants are described.

Abstract: A passive transponder may be encoded with a number or code of up to 64 binary bits and then mounted to virtually any prosthesis implanted in a human, such as a breast implant. After implantation, the transponder's code may be conveniently read with a hand held electromagnetic reader which may merely be brought within proximity of the transponder. The encoded transponder may thus be read in a non-invasive procedure and without the use of any sophisticated or potentially harmful medical equipment or technology such as X-ray. The information encoded in the transponder may correspond to patient demographics and implant data to aid in tracking the implant's manufacturer and use for medical as well as legal reasons.

Abstract: A medical implant with an external surface layer of silicone elastomer and having an open-cell structure is made by applying solid particles to the external surface layer of the implant before it is cured, curing the external surface layer with the solid particles embedded therein and then dissolving the solid particles with a solvent that does not dissolve the silicone elastomer. An implant having such an external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.

Abstract: A rheologically modified, osmotically balanced dispersion for an implant for the body. The dispersion includes an osmotic control agent of preferably polyvinylpyrrolidinone, a rheological agent of preferably guar gum, and an antimicrobial. Methods for filling an implant are also disclosed. The osmotic control agent or first polymeric osmotic control agent is present in the dispersion in an amount effective to substantially balance the osmotic pressure of the implant with the osmotic pressure of the portion of the body into which it is implanted. The rheological agent or second polymeric agent forms a three-dimensional network and is present in the dispersion in an amount effective such that the fill material is pseudoplastic. Both the first and second polymeric agents are biocompatible.

Abstract: A new soft tissue implant filling material is disclosed. The material may be polyvinylpyrollidone, polyvinyl alcohol, hydroxypropylmethyl cellulose, polyethylene oxide, hyaluronic acid, sodium or calcium alginate, hydrogel polyurethane, hydroxyethyl starch, polyglycolic acid, polyacrylamide, hydroxyethylmethacrylate (HEMA), and several naturally derived biopolymers including sodium kinate, seaweed, and agar.

Abstract: A breast prosthesis for implantation beneath the skin is disclosed. In one preferred embodiment the prosthesis has an outer elastic shell which encloses a biocompatible fluid and a silicone foam insert of unitary construction having the shape and approximate consistency of breast tissue. The foam insert occupies substantially the entire volume enclosed by the shell of the implantable prosthesis and consists of a foam body that is molded to the shape of the breast. The foam body has both open-cell and closed-cell characteristics. Portions of the foam insert are closed-cell with open-cell passageways threading themselves throughout the structure. The insert is of unitary construction and made by (a) heating a mold to an appropriate temperature; (b) mixing air bubbles into a dispersion of uncured silicone; (c) injecting the bubble-laden, uncured silicone into the preheated mold; and (d) applying a vacuum until the foam insert cures.

Abstract: An endoscopic assisted mastopexy, with or without augmentation, or an endoscopic assisted reduction mammoplasty is disclosed in which an incision is made at a point on the body remote from the breast which is not ordinarily visible, such as in a preexisting scar, under an armpit or elsewhere accessible to the upper hemisphere of the breast. In the mastopexy with augmentation, dissection is carried up to the fascia of the pectoralis muscle and above the fascia and with the scope for visualization, an endotube is inserted from the incision over the pectoral fascia. A tissue expander is inserted and inflated to dissect the fascia away from the muscle to form a posterior pocket and then removed. With blind dissection, with external palpation, using scissors, from the incision, the skin is undermined in the upper quadrant.

Abstract: Testicular prosthesis and method of manufacturing wherein the testicular prosthesis has a saline or other biologically safe fluid filled silicone elastomer shell which includes a self-sealing injection site for filling the prosthesis and a tab for suturing the testicular prosthesis into position in the scrotum. A method of filling and a method of identifying and serialization is also provided.

Abstract: An implant and coverings for an implant for use in the human body are disclosed. Coverings for implants are constructed to present a biocompatible surface to the body and to provide a textured surface which serves to disorganize scar tissue which forms around the implant. Filaments of expanded PTFEe are attached to a stretch fabric backing in a loose weave configuration. Silicone molded in geometric patterns may be employed to present a textured surface. Compressive structures may be beneficially used on the surface of the implant or in the interior of the implant. Foam is one such compressive structure. Hexagonally shaped compressive cells containing fluid, gas, gel or foam are adapted to receive an insert which contains an outer biocompatible coating. A valve or port is provided to communicate between the cell and the body. Expansion means may be provided to expand the implant in a desired direction.

Abstract: A temporarily implantable organ displacement implant is comprised of a bladder with a one-way valve for being filled with a fluid for displacement of a healthy organ from a tissue site desired to be irradiated by radiation therapy. This organ displacement implant is substantially radiolucent which thereby facilitates its placement and minimizes its interference with the radiation therapy.

Abstract: A non-bleeding surgical breast implant containing mechanically stable 3-dimensional crosslinked hydrogel filler material hydrated directly inside a shell. Discrete polymeric hydrogel units at their smallest dehydrated solid dry state are placed into inconsiderable volume of a completely deflated shell through a sealable hole and subsequently are hydrated to a desired size either prior to or following implantation into a non-bleeding breast implant.

Abstract: Testicular prosthesis and method of manufacturing wherein the testicular prosthesis has a saline or other biologically safe fluid filled silicone elastomer shell which includes a self-sealing injection site for filling the prosthesis and a tab for suturing the testicular prosthesis into position in the scrotum. A method of filling and a method of identifying and serialization is also provided.

Abstract: The invention provides a biocompatible surgical implant particularly useful for breast or testicular reconstruction or augmentation comprising a stabilized fibrin semisolid, optionally sealed in a shaped shell. Preferred starting material for production of the implant is whole plasma from autologous or homologous donation, concentrated with respect to fibrinogen.